The truth about Loper Bright v. Raimondo.
If you follow some ex-FDA staff like I do, you'll likely have noticed that they're talking about this case.
Last Friday the US Supreme Court's decision in Loper Bright Enterprises v. Raimondo overruled the legacy Chevron U.S.A Inc. v Natural Resources Defense Council decision from 1984 - i.e. the Chevron Doctrine that's guided or at the very least influenced the pharmaceutical industry for the past 40 years.
Under Chevron, a two-step framework was put in place that guided review of agency actions.
1. The reviewing court had to first determine whether the legislation was clear/unambiguous. If the statute was clear, the court had to apply the law as written even in the overseeing agency had a differing opinion.
2. If the court determined that the meaning of the law was unclear or that the issue had been delegated to the overseeing agency, Chevron required that the court deer to the agency's interpretation as long as it was "reasonable."
In essence, agencies were weighted to win in the majority of cases where the reviewing courts found that the law was ambiguous. This meant that many pharmaceutical company's were reluctant, at best, to challenge FDA's interpretations. And this could apply even in cases where the agency's interpretation did not appear inline with common interpretation of the same law.
Under Loper Bright, reviewing courts are not required to "𝘦𝘹𝘦𝘳𝘤𝘪𝘴𝘦 𝘵𝘩𝘦𝘪𝘳 𝘪𝘯𝘥𝘦𝘱𝘦𝘯𝘥𝘦𝘯𝘵 𝘫𝘶𝘥𝘨𝘮𝘦𝘯𝘵 𝘪𝘯 𝘥𝘦𝘤𝘪𝘥𝘪𝘯𝘨 𝘸𝘩𝘦𝘵𝘩𝘦𝘳 𝘢𝘯 𝘢𝘨𝘦𝘯𝘤𝘺 𝘩𝘢𝘴 𝘢𝘤𝘵𝘦𝘥 𝘸𝘪𝘵𝘩𝘪𝘯 𝘪𝘵𝘴 𝘴𝘵𝘢𝘵𝘶𝘵𝘰𝘳𝘺 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺" and "𝘮𝘢𝘺 𝘯𝘰𝘵 𝘥𝘦𝘧𝘦𝘳 𝘵𝘰 𝘢𝘯 𝘢𝘨𝘦𝘯𝘤𝘺 𝘪𝘯𝘵𝘦𝘳𝘱𝘳𝘦𝘵𝘢𝘵𝘪𝘰𝘯 𝘰𝘧 𝘵𝘩𝘦 𝘭𝘢𝘸 𝘴𝘪𝘮𝘱𝘭𝘺 𝘣𝘦𝘤𝘢𝘶𝘴𝘦 𝘢 𝘴𝘵𝘢𝘵𝘶𝘵𝘦 𝘪𝘴 𝘢𝘮𝘣𝘪𝘨𝘶𝘰𝘶𝘴."
As a result, agency's like FDA may find themselves more open to legal challenge by manufacturers than they have been in 40 years.
H͟e͟r͟e͟'͟s͟ ͟t͟h͟e͟ ͟s͟u͟m͟m͟a͟r͟y͟:
Loper Bright ends the practice of courts deferring to agency interpretations of ambiguous statutes, and requires courts to exercise independent judgment instead. The decision will likely increase legal challenges against FDA actions and lead to heightened scrutiny of FDA's regulatory authority and decisions, affecting market exclusivity, agency rulemaking, and drug approvals within FDA-regulated industries.
#pharmaceuticals #pharmaceuticalmanufacturing
Source material and further reading linked here:
https://lnkd.in/eUcU8NZy
https://lnkd.in/eWaG_PEk
https://lnkd.in/eTZ2GTFx
Share your thoughts about Loper Bright in the comments, will it have any impact?
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